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Up Front | Feb 2009

Ethical Considerations for Refractive Lens Exchange

Preoperatively, patients must be aware of all surgical options, fees, and potential add-ons.

On the surface, one might conclude that traditional medical thinking would deny credence to any form of purely refractive surgery. Why would, or should, the physician and patient risk the potential consequences of corneal or intraocular invasive surgery to reduce or eliminate the need for spectacles or contact lenses? This conundrum is further complicated by the significant sums of money paid directly from the patient to the surgeon for these services.

Patients have long considered spectacles to be a major hindrance to their desired lifestyle, both aesthetically and functionally, as has been revealed in quality-of-life surveys.1-3 Given that reason alone, there is a markedly successful contact lens industry in the developed world; however, contact lenses, too, have downsides. Moreover, precedent for other forms of elective and aesthetic surgery has been clearly established; rhinoplasty, breast augmentation, and liposuction are examples. Procedures of this nature have been practiced for many years, paving the way for the concept of refractive surgery. Therefore, I believe we can conclude that it is both appropriate and ethical to perform refractive surgery in general, and refractive lens exchange (RLE) in particular, given certain caveats.

When is it appropriate to offer RLE? Patients who may not be good candidates for corneal refractive surgery, such as those with a thin cornea, high refractive error, or those who may be poor candidates for a phakic IOL, may be considered for RLE surgery. The decision to remove the clear lens for refractive purposes must be carefully considered in view of its invasive nature, particularly for highly myopic eyes, as the risk for retinal detachment in this group is greater than 8% after 7 postoperative years.4 Therefore, patients who are good candidates for less invasive, less risky, and less expensive refractive surgery should be offered such procedures before RLE is considered. Surgeons unfamiliar with those procedures are obliged to refer patients rather than to perform RLE.

RLE has broader indications than corneal refractive or phakic IOL surgery, as it may be successfully performed for almost any refractive condition. On an individual patient basis, the surgeon is obligated to discuss the various refractive surgical procedures and why RLE may be the most promising procedure for that particular patient.

Ethical considerations come into great significance when the surgeon is confronted with a patient who has an interest in spectacle independence and exhibits modest degrees of cataract. If cataract surgery is not medically indicated because of reduced visual function, RLE will serve the patient's needs, albeit at a significant out-of-pocket expense. In these situations, and in the United States, the surgeon typically receives greater fees for RLE than for cataract surgery. Whereas RLE comes with an out-of-pocket expense to the patient, cataract surgery is reimbursed by health insurance. In such cases, the surgeon is obliged to inform the patient that with additional time the cataract is likely to worsen, and at that time, he will qualify for surgery under medical insurance coverage. Patients must not be coerced to have—and pay for—RLE surgery to save them from the future need for cataract surgery. Physicians are ethically obligated to perform cataract surgery when appropriately indicated by patient visual symptoms, even in relatively early stages of the disease, rather than to suggest that the patient pay the generally greater fees associated with RLE.

Indications for surgery must also be consistent with the surgeon's skills and the current level of technological advances. Each surgeon must provide his patients with realistic expectations regarding the quality of vision following surgery, particularly where presbyopia-correcting IOLs are concerned. For example, most surgeons will not offer RLE for the sole indication of presbyopia—emmetropic presbyopia is not considered an appropriate indication for RLE, considering the current state of the art. Given improved technology over time, this is likely to change.

The surgeon offering RLE must recognize the mandate for high-quality surgery with reliable outcomes, and his complication rate should be low, perhaps lower than those in published outcome studies. The surgeon should also have a method for controlling surgically induced astigmatism and reducing pre-existing astigmatism. He should be able to provide prospective patients with outcomes of his surgical cases, if requested. Patients also need to understand the various choices for lens implants and be guided toward those devices that would most likely serve their needs and wishes.

The informed consent must provide the same information supplied for cataract surgery; however, it must also include the higher risk factor of retinal detachment in young myopes, the increased risk of suprachoroidal effusion and hemorrhage in highly hyperopic eyes, the loss of natural accommodative function in young individuals, and the potential for an unsatisfactory refractive outcome requiring additional surgery. Lastly, patients must be made fully aware of all surgical fees and potential add-ons.

One final note: The comments in this article are consistent with practice patterns in the United States. It could be that differing guidelines are appropriate elsewhere.

Samuel Masket, MD, is in private practice in Century City, California, and is a Clinical Professor of Ophthalmology at the UCLA Geffen School of Medicine, Jules Stein Eye Institute, Los Angeles. Dr. Masket states that he is on the speaker's bureau and a consultant to Alcon Laboratories, Inc. He is also a paid consultant to Visiogen, Inc., Power Vision, and Othera. Additionally, Dr. Masket receives speaker's honoraria from Bausch & Lomb, Allergan, and Carl Zeiss Meditec. Dr. Masket may be reached at tel: +1 310 229 1220; e-mail: avcmasket@aol.com.

  1. Vitale S, Schein OD, Meinert CL, Steinberg EP. The refractive status and vision profile: a questionnaire to measure vision-related quality of life in persons with refractive error. Ophthalmology. 2003;110(12):2292-2301.
  2. Hays RD, Mangione CM, Ellwein L, Lindblad AS, Spritzer KL, McDonnell PJ. Psychometric properties of the National Eye Institute-Refractive Error Quality of Life instrument. Ophthalmology. 2003;110(12):2302-2309.
  3. McDonnell PJ, Mangione C, Lee P, Lindblad AS, Spritzer KL, Berry S, Hays RD. Responsiveness of the National Eye Institute Refractive Error Quality of Life instrument to surgical correction of refractive error. Ophthalmology. 1999;106(12):2281-2284.
  4. Colin J, Robinet A, Cochener B. Retinal detachment after clear lens extraction for high myopia: seven-year follow-up. Ophthalmology. 2001;108(2):239.

Feb 2009